Considerations for environmental sustainability in clinical trials: A case study simulation of the REVISE trial

More environmentally sustainable clinical trials are needed. This case study simulation, based on a secondary analysis of the Re-Evaluating the Inhibition of Stress Erosions (REVISE) trial, was designed to estimate the carbon emission and monetary impact if the proton pump inhibitor had been switched from intravenous to enteral administration as soon as possible.

In REVISE, only intravenous study drug was used, to avoid additional pharmacy costs associated with preparing study drug and placebo for enteral administration, to streamline trial management, and minimize transition-associated administration errors. The median duration of intravenous pantoprazole (or placebo) administration was 5 days; we assumed patients would transition to enteral lansoprazole on day 2 for the remaining intervention period. Greenhouse gas emissions from the intervention and waste generated were estimated using cost-based emissions factors for drugs and weight-based emission factors for waste. Monetary costs were derived from average acquisition costs from REVISE participating centers.

Allowing step-down to enteral lansoprazole on day 2 of an average 5-day course would have reduced greenhouse gas emissions by 28% compared with a 5-day intravenous pantoprazole regimen (9.84 vs. 13.6 kgCO₂e). Considering the entire trial, a complex intravenous/enteral intervention would have saved approximately 9000 kgCO2e and halved drug-related costs including aquisition, preparation and administration supplies.

This simulation demonstrates that enabling transition from intravenous pantoprazole to enteral lansoprazole may have yielded substantial reductions in both greenhouse gas emissions and costs. Considering environmental stewardship represents an important step towards more sustainable clinical trials.